BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXTAG COV EXTENDED PANEL

    MDR report key: 12021166 · Received June 17, 2021

    Report

    Report Number
    3002777243-2021-00002
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    February 22, 2021
    Report Date
    June 10, 2021
    Manufacturer
    LUMINEX MOLECULAR DIAGNOSTICS, INC.
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED INJURY OR DEATH AT THE TIME OF THIS REPORT. THE MDR IS BEING SUBMITTED UNDER DEVIATION (B)(4). PURSUANT TO THE OBLIGATIONS OF THE EMERGENCY USE AUTHORIZATION, AND PER COMMUNICATION RECEIVED FROM FDA ON OCTOBER 7, 2020.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE CUSTOMER REPORTED THAT THEY HAVE RECENTLY SEEN SOME SAMPLES COME UP POSITIVE FOR ONLY ORF1AB AND E GENES WITH STRONG SIGNALS, BUT NO SIGNAL FOR THE N GENE. THEY WERE CURIOUS IF THIS WAS A RESULT OF THE NEW VARIANT GENE. TECHNICAL SUPPORT NOTED THAT THIS IS NOT A DISCREPANCY SINCE ONLY 1 TARGET NEEDS TO BE POSITIVE (N, ORF1AB, OR P GENE) IN ORDER TO GET COV POSITIVE. TECHNICAL SUPPORT REQUESTED THE DATA AND CHECKED TO SEE IF THE CUSTOMER COULD SHIP THE SAMPLES IN QUESTION TO LUMINEX FOR VARIANT EVALUATION. ON (B)(6) 2021, THE CUSTOMER NOTIFIED TECHNICAL SUPPORT THAT THEY WILL BE REPEATING THE SAMPLES THAT WERE POTENTIAL VARIANTS (NO N GENE DETECTED) AND WILL SHIP THESE SAMPLES TO LUMINEX FOR POTENTIAL SEQUENCING IF THE RESULTS REPEAT. CONCLUSION: ON (B)(6) 2021, THE CUSTOMER CONFIRMED THAT ALL THE REPEATS CAME BACK NEGATIVE SO THEY WILL NOT SEND THE SAMPLES TO LUMINEX FOR SEQUENCING. CUSTOMER ALSO CONFIRMED THAT ALL THE POSITIVE CONTROLS/INTERNAL CONTROLS WERE FINE. FURTHER INVESTIGATION WAS NOT NEEDED ANYMORE. AT THIS TIME, THIS CASE WILL BE SUBMITTED AS AN MDR BASED ON FDA'S GUIDANCE RECEIVED ON OCTOBER 7TH, 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918630 NXTAG COV EXTENDED PANEL NXTAG COV EXTENDED PANEL QJR LUMINEX MOLECULAR DIAGNOSTICS, INC. IK054C-0050, IK054C-0051

    Patients

    Seq Age Sex Outcome Treatment
    1